Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer

• Status: Completed
• Trial end date: 2018-04-04
• Target enrollment: 0
• Participant gender: All

Summary

Single-arm study to determine disease control rate in second- (or later) line treatment with cabazitaxel after the failure of palliative primary treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest; Prof. Dr. S.E. Al-Batran

Criteria

Inclusion Criteria:

1. Histologically confirmed inoperable and/or metastatic adenocarcinoma of the oesophagogastric junction or stomach

2. Progression of a measurable lesion (RECIST) on previous palliative chemotherapy. Neoadjuvant/adjuvant treatment is not counted, unless progression occurs < 6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one line.

3. Male and female patients aged > 18 years

4. ECOG ≤ 1

5. neutrophils ≥ 1500/µl

6. Haemoglobin ≥ 9 g/dl

7. Platelets ≥ 100,000/µl

8. AST/SGOT and/or ALT/SGPT ≤2.5 x ULN;

9. Total bilirubin ≤1.0 x ULN

10. Serum creatinine ≤ 1.5 times the normal value, or creatinine clearance ≥ 60 ml/min

11. Written patient informed consent

Exclusion Criteria:

1. A history of severe hypersensitivity to taxanes (≥ grade 3) or to medicinal products containing polysorbate 80 (≥ grade 3)

2. Active CAD, cardiomyopathy or NYHA stage III-IV heart failure

3. Malignant secondary disease dating back < 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin)

4. Severe secondary internal diseases, including uncontrolled diabetes mellitus or an acute infection

5. Concomitant medication or planned treatment with strong CYP450 3A4/5 inducers or inhibitors (list of medicinal products in the appendix) or the relevant medicinal products were not discontinued a minimum of one week before treatment

6. Peripheral polyneuropathy > NCI grade II

7. Severe hepatic impairment (AST/ALT > 2.5 x ULN, , bilirubin > 1 x ULN)

8. Chronic inflammatory bowel disease

9. Participation in another study

10. Pregnancy or lactation